ClinicalTrials.gg
Not yet recruitingNCT07348445Updated Jan 16, 2026

Clinical Trial of Digital Therapeutics (One.Dr) for Suspected Orthostatic Hypotension Patients

An interventional study of Digital therapeutics (One.Dr Application) and Digital therapeutics (Sham Application) in Hypotension and Orthostasis, sponsored by Yonsei University. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by Yonsei University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Participants who meet the inclusion/exclusion criteria in the Screening visit are randomly assigned 1:1 to the treatment group or the sham control group. The two-week period after Screening is the Run-in period, and the participant performs self-measured blood pressure monitoring, records data using the One.Dr application, and records symptoms and events related to orthostatic hypotension such as dizziness in the application. Only those who have completed the Run-in period will enter the Intervention period (for 6 weeks at 3-8 weeks), and according to each allocation group, non-pharmaceutical treatment education is provided for the treatment group and general health knowledge education is provided for the sham control group.

02

Conditions studied

  • Hypotension
  • Orthostasis
03

In context

Hypotension

885 studies on the registry are indexed under Hypotension; 195 are open to participants now.

This study's planned enrollment of 86 is close to the median of 87 across 590 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults over 19 years of age suspected of orthostatic hypotension due to symptoms such as dizziness within one year
  2. Participants who are able to walk and conduct this clinical trial or cooperate with their care providers

Exclusion criteria

Exclusion Criteria:

  1. Participants diagnosed with diseases that cause dizziness other than orthostatic hypotension, such as otolithiasis and stroke, within one year
  2. Severe anemia ( \<8.0 g/dL, based on the latest test results within 12 months)
  3. Participants unable to use smartphones (android phones) and/or smart watches
  4. Participants with chronic diseases less than one year of , such as malignant tumors
  5. Participants with severe heart valve disease or severe heart failure ( \<35%) who have been hospitalized for acute exacerbation within the last 3 months
  6. Participants with recent rapid and unintended weight loss (5% or more than 5 kg within 6 months)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
86 participants (estimated)

Study arms

  • Experimental
    One.Dr Application

    Other: Digital therapeutics (One.Dr Application)

  • Sham comparator
    Sham Application

    Other: Digital therapeutics (Sham Application)

Interventions

  • OtherDigital therapeutics (One.Dr Application)

    An application that provides educations and non-pharmaceutical treatment (participant customized content) for orthostatic hypotension via a smart device

  • OtherDigital therapeutics (Sham Application)

    An application that provides general health knowledge via a smart device

06

What researchers measure

Primary outcomes

  1. The changes in orthostatic SBP or DBP drop between the Run-in period and the Intervetion period

    Orthostatic BP will be recorded during the Run-in period (2 wks) and the Intervetion period (6 wks). The orthostatic BP drops are expected to decrease in the treatment group than in the sham control group.

    Time frame: For 8 weeks after first use of digital therapeutics

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07348445
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jan 16, 2026
Start date
Jan 2026 (estimated)
Primary completion
Apr 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
Jan 16, 2026

Study contacts

Jung-Sun Kim, MD
Contact
kjs1218@yuhs.ac
02-2228-8457

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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